Controlling Hyperactive Immunity With Long-lived Lymphocytes
This study is a Phase 1/2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolera
| Condition(s) | Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Autoimmune Rheumatologic Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This study is a Phase 1/2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolerate it, and whether it may help reduce disease activity or improve symptoms. QEL-005 is made from a participant's own white blood cells (autologous cells). These cells are collected and then changed in a laboratory using genetic methods to create specialized immune cells called CAR-T regulatory cells that target a protein on B cells called CD19. These modified cells are then given back to the participant by intravenous (IV) infusion. To take part, eligible participants will fi |
| Who can participate | Inclusion Criteria: * Participants must be at least 18 years of age at the time of signing the informed consent. * Up to date vaccination status and no planned vaccinations for post 3 months infusion * Adequate haematological, liver and renal function * Willing to undergo annual influenza vaccination * Willing to enter a 15-year follow-up * Eastern Cooperative Oncology Group (ECOG) performance status grade \< 3 * Able and willing to use a highly effective method of contraception * Stable dose of steroid prior to screening Specific inclusion criteria for participants with difficult to treat rheumatoid Arthritis (D2TRA) only: * Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria * Diagnosis of D2TRA per 2021 EULAR criteria * Evidence of clinically active disease a defined by v |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Quell Therapeutics Limited |
| Locations | Birmingham, United Kingdom; Leeds, United Kingdom; London, United Kingdom; London, United Kingdom; Newcastle, United Kingdom; Oxford, United Kingdom |
| Start date | 2026-04 |
| NCT ID | NCT07473154 |
| Official listing | https://clinicaltrials.gov/study/NCT07473154 |